Kornimate/medical-research-clean huggingface dataset:
a study to assess the long-term safety, tolerability, and efficacy of bimekizumab in the treatment of subjects with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (psa).


Eligibility criteria:
inclusion criteria: * in the opinion of the investigator, the subject is expected to benefit from participation in this open-label extension study * subject completed pa0010 \[nct03895203\] or pa0011 \[nct03896581\] without meeting any withdrawal criteria * female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception exclusion criteria: * female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (imp) * subjects who meet any withdrawal criteria in pa0010 or pa0011. for any subject with an ongoing serious adverse event (sae), or a history of serious infections (including hospitalizations) in the feeder studies, the medical monitor must be consulted prior to the subject's entry into pa0012, although the decision to enroll the subject remains with the investigator * subject has a positive or 2 indeterminate interferon gamma release assays (igras) in one of the feeder studies, unless appropriately evaluated and treated

Keywords: psoriatic arthritis psa bimekizumab
efficiency of three different methods in reducing pain in children during intravenous cannulation

Conditions: Child, Only

Summary: purpose: this study investigates the effects of squeezing a soft ball, using a kaleidoscope, or blowing bubbles during intravenous cannulation on the pain and fear of children between the ages of 4 and 6. design and methods: this study is a randomised controlled study. in the study, there were 30 children in the soft ball group, 30 children in the kaleidoscope group, 30 children in the bubbles group, and 30 children in the control group.

15 minutes before the intravenous cannulation procedure, the second researcher interviewed the parents and the children in squeezing soft ball, kaleidoscope, blowing bubbles and control groups separately and filled in descriptive information form and children's fear scale. after randomization, the second researcher, the child and the parent went to the blood collection room for the procedure. children in the kaleidoscope group were given the kaleidoscope before intravenous cannulation and they were shown how to use it. the children were told to look at the kaleidoscope during the procedure until the procedure ended. the children in the squeezing soft ball group were given the ball before the procedure. they were told to squeeze and loosen the ball with the hand that was not used for the procedure while intravenous cannula was being inserted. the children in the blowing bubble group were shown the bubble blower before intravenous cannulation and they were told how bubbles were formed and how they would blow. during intravenous cannulation, the child blew the blower. routine procedures were applied on the children in the control group without any interventions. inserting the intravenous cannula took 3-5 minutes. the procedure was carried out in the same room by the same nurse for four of the groups. after the intravenous cannulation procedure ended, a researcher and parents filled in faces pain scale-revised and children's fear scale separately and independently to find out the level of pain and fear experienced by the child during the procedure.

Eligibility criteria:
inclusion criteria: * parents who agreed to participate in the study exclusion criteria: * visually impaired child * mentally retarded child * speech impaired children

Keywords: blowing bubbles child fear kaleidoscope pain squeezing soft ball
safety and efficacy of electroconvulsive therapy (ect) for behavioural and psychological symptoms of dementia (bpsd)

Conditions: Dementia

Summary: this is a prospective, open-label, observational study of the efficacy and safety of ect for bpsd. there is no control or comparison group. subjects will be compared on outcome measures pre- and post-ect (and/or with a repeated measures design). target sample size is 30 subjects over three years

the study population are patients whom have a diagnosis of dementia and has behavioural and psychiatric symptoms of dementia (bpsd). in this study, the participants will have already been treated with antipsychotic medications as per usual practice but still do not have adequate symptoms control. one of the options in current clinical practice is to consider electroconvulsive therapy (ect) for treatment-resistant bpsd, particularly in those with psychosis and/or substantial aggression. therefore, the study involves offering ect to these individuals and measuring the patient's clinical status and severity of symptoms before and after ect treatments by using standardized rating scales. further, background information about the patient will be collected, such as their age and medical conditions. ect for bpsd has been done previously as reported in the medical literature. it has shown significant benefit for individuals when medication does not provide enough symptomatic relief. this research project is part of a larger multi-site study done in conjunction with ontario shores academic research group in ontario, canada. active recruitment began in ontario since october 2012, but our university of british columbia (ubc) site is hoping to recruit further subjects to the total of 30 participants between the two sites.

Eligibility criteria:
inclusion criteria: * severe bpsd: bpsd of sufficient severity that the safety of the patient or others precludes the possibility of discharge to any non-hospital environment. * failed "standard of care for bpsd": * non-pharmacological treatments (see clinical practice guideline) are of insufficient benefit to allow discharge to any non-hospital environment, and * pharmacological treatments are of insufficient benefit to allow discharge to any non-hospital environment. pharmacological treatments must consist of the following prescribed specifically for bpsd: * at least three atypical antipsychotic agents each for at least 4 weeks * at least one of the following for at least four weeks: an antidepressant, a cholinesterase inhibitor, and/or and n-methyl-d-aspartate (nmda) receptor antagonist (i.e. memantine). * provided informed (substitute) consent to their attending psychiatrist for off-label treatment of bpsd with ect as per the health care (consent) and care facility (admission) act, and institutional policies and procedures. * been medically-cleared for ect by anaesthesia as per the usual pre-ect work-up for patients admitted to the geriatric psychiatry units. exclusion criteria: * patients that are medically unfit to undergo ect as per consultation with an anesthetist.

Keywords: electroconvulsive therapy dementia
device study to evaluate the detection and characterization of middle ear fluid in children

Conditions: Otitis Media With Effusion; Middle Ear Effusion

Summary: the study has three objectives: 1. to determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy) 2. if fluid is present to characterize the fluid as thick or thin 3. evaluate the safety of the device


Eligibility criteria:
inclusion criteria: * 6 months to 17 years * scheduled to undergo myringotomy procedure exclusion criteria: * mastoiditis * tympanostomy tubes * chronic middle ear disease * otitis externa * perforations of the middle ear * use of antibiotic ear drops within 2 days of surgery * systemic antibiotic use

Keywords: otitis media with effusion middle ear effusion
acupuncture intervention for aya with cancer

Conditions: Palliative Care

Summary: the aim of the study is to innovatively extend acupuncture research in adult oncology to adolescents and young adults (aya) by piloting a tailored acupuncture protocol for pain management in aya in the children's hospital of philadelphia (chop's) center for integrative health.

acupuncture is an integrative medicine (im) with a growing evidence base that is often incorporated into comprehensive pain management in adult oncology. however, it is under-utilized and under-researched in pediatric oncology, especially with adolescents and young adults (aya). acupuncture is a promising palliative therapy to manage pain and improve quality of life (qol) of aya. aya are underserved and typically endure more morbidity and longer treatments than younger patients. more than half report at least three debilitating cancer-related symptoms and their qol is significantly lower compared to norms, with symptoms being the greatest contributor to poor qol. not surprisingly, aya identify pain management as an unmet need, leading a majority of aya to want information on im or seek it for treatment. given the potential benefit of acupuncture for addressing unmet needs of aya by reducing physical suffering, and the established difficulty with pain management using conventional methods, there is a critical need to establish the efficacy of acupuncture for pain management in aya. the few studies that have evaluated acupuncture in pediatric oncology, demonstrating it to be safe, accepted, and associated with symptom relief are uncontrolled, retrospective, and/or unprotocolized, and none focus on aya. to establish the evidence base for acupuncture in aya oncology, research is needed to determine and test optimal acupuncture protocols.

Eligibility criteria:
aya inclusion criteria: * report a pain severity score of ≥ 4 in last 7 days on an 11-point (0-10) numerical rating scale and reports a pain distress score of ≥ 2 on a 5-point numerical rating scale * males or females age 13 to 24 years * on treatment for cancer for at least one month or within two years of completing treatment * not expected to be terminal within the next 6 months * absence of infection or bleeding disorder * physically and medically able to get to the acupuncture clinic * able to read and write english aya exclusion criteria: * absence of inclusion criteria above * parents'guardians or subjects who, in the opinion of the investigator, may be non-compliant with the study schedules or procedures * cognitive impairments that would limit aya's ability to complete measures or to independently care for health as determined by medical team parent/guardian inclusion criteria: * be primary parent/guardian of the aya participant * be able to read and write english parent/guardian exclusion criteria: * cognitive impairments that would limit the parent/guardian's ability to complete measures * absence of inclusion criteria above

Keywords: pain management of adolescent and young adults with cancer
one-leg standing radiograph: a novel technique to evaluate the severity of oa knee

Conditions: Severity of OA Knee; Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph

Summary: the purpose of this study is assess the severity of osteoarthritic knee between one-leg and both-leg standing radiograph in primary oa knee

all patients were performed digital radiographs which one-leg and both-leg standing anteroposterior view. medial and lateral joint space width were measured. the severity of oa knee was identified by the kellgren-lawrence (kl) classification.

Eligibility criteria:
inclusion criteria: * bilateral knee pain more than 3 months exclusion criteria: * inflammatory oa knee * previous knee injury * previous knee infection * previous knee surgery * pregnant women * unable to bear weight on one leg

Keywords: osteoarthritis of the knee weight bearing radiograph kellgren-lawrence classification joint space width one-leg standing view
the efficacy and safety of fang yi qing feng shi granules in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the aim of this study is to evaluate the efficacy and safety of fang yi qing feng shi granules in subjects with rheumatoid arthritis.

fang yi qing feng shi granules is the chinese patent medicine, which contains 8 kinds of chinese medicine . fang yi qing feng shi granules was approved by china food and drug administration (cfda) in 2005, produced by means of modern technology by maoxiang group jilin pharmaceutical co., ltd.the study is a multi-center, double -blind, placebo -controlled, randomized in chinese subjects with rheumatoid arthritis to assess treatment effect and safety in the subjects treated with fang yi qing feng shi granules versus subjects treated with placebo.

Eligibility criteria:
inclusion criteria: 1. subjects have the diagnosis of rheumatoid arthritis in active state. 2. subjects have the traditional chinese medicine (tcm) diagnosis ofarthralgic syndrome with the sign of dampness obstructing connecting vessel。 3. subjects must stop the medicine at least three month，which is diseases modifying anti-rheumatic drugs(including glucocorticoids). 4. male or female subjects, between the ages of 18 and 65 years old. 5. joint function grading and ray classification are both in ⅰ～ⅲ. 6. subjects agree to participate in this study and sign the informed consent form. exclusion criteria: 1. subjects with systemic lupus erythematosus,sicca syndrome, or severe osteoarthropathy will be excluded. 2. subjects with severe rheumatic arthritis are loss of ability 3. allergic to test drugs(basic treatment or drug combination),allergic constitution(allergic to two or more drugs). 4. female subject who was pregnant or breast-feeding or considering becoming pregnant. 5. subjects with sever diseases in cardiovascular, brain, lung, liver, kidney and hematopoietic system. 6. the liver function (alt,ast) and kidney function（bun,cr）is higher than normal. 7. the blood routine (leukocyte count,platelet count)is lower than normal. 8. subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
distance learning and neck problems during pandemic period

Conditions: Neck Pain

Summary: for people who use computers a lot, work-related musculoskeletal disorders of the neck are a common problem . it is generally agreed that the etiology of work-related neck disorders is multidimensional which is associated with, and influenced by, a complex array of individual, physical and psychosocial factors.

academic staff work involves diverse activities, both in and out of lecture-rooms, designing course curricula, developing lecture and tutorial plans and materials, providing students with information in an interesting and understandable manner, setting questions, and marking examinations .these activities usually involve long periods of sitting and standing, placing a physical demand on the lower back, cervical spine and the vertebral column in general, thus contributing to neck and shoulder discomfort .lecturers use computers extensively and are thus exposed to many of the same risk factors to which 'office workers' are exposed. using a computer is associated with poor neck posture most often in a forward head position, which is thought to be one of the most common causes of neck, head and shoulder tension and pain . neck pain is costly in terms of treatment, individual suffering, and time lost due to work absenteeism . effective performance of academic staff of the university is very important as the key factors to a successful day to day running of any university system .

Eligibility criteria:
inclusion criteria: * at least one year of work experience in the current position as academic stuff. exclusion criteria: * spinal deformities or specific medical condition affecting the cervical spine (e.g., ankylosing spondylitis, radiculopathy, tumors, infection and disc prolapse) * history of spinal surgery * previous head or neck trauma

Keywords: online learning neck pain covid-19
the effect of brochure-based education on patients planned for nose surgery

Conditions: Nursing Caries

Summary: the study was planned as a randomized controlled trial to determine the effect of brochure-based education on fear and anxiety in patients scheduled for nose surgery.it is planned to collect research data in hatay mustafa kemal university hospital otorhinolaryngology clinic between june 2022 and june 2023.the population of the research will be the patients who are hospitalized in the otorhinolaryngology clinic of the aforementioned hospital and are planned for nasal surgery. the sample of the study, on the other hand, will consist of 52 patients who meet the inclusion criteria and agree to participate in the study verbally and in writing.the data of the study were collected by using the personal information form, the surgical fear scale and the surgical anxiety scale, which were prepared in line with the literature.the data will be analyzed with the spss package program.


Eligibility criteria:
inclusion criteria: * 18 years and over, 65 years and under, * being literate, * to be able to understand and speak turkish * first time nose surgery, * agreeing to participate in the research. exclusion criteria: * having any psychiatric disorder that may reduce the ability to comprehend and understand * the surgery was canceled for some reason.
evaluation of proteome multimarker panel with multiple reaction monitoring as a surveillance for hepatocellular carcinoma

Conditions: Liver Cirrhosis

Summary: most current guidelines recommend hepatocellular carcinoma (hcc) surveillance with ultrasound and alpha feto-protein (afp) every 6 months for individuals with risk factors. however, the sensitivity of ultrasound for hcc detection is significantly reduced, especially in high-risk cirrhotic patients. in this study, the investigators aim to evaluate the efficacy of multiple reaction monitoring (mrm)-based multimarker panel as a surveillance tool for hcc. during two surveillance periods (starting from the time of voluntary consent and 6 months later), participants receive ultrasound, afp, and mrm-based multimarker panel analysis. patients who are suspected of hcc based on one of three tests undergo a contrast-enhanced ct scan within 6 weeks. after 6 months from the second surveillance period, the investigators re-evaluate the development of hcc using contrast-enhanced ct and afp. the diagnostic accuracy of mrm-based multimarker panel is compared to ultrasound and afp.


Eligibility criteria:
inclusion criteria: * patients with liver cirrhosis aged over 18 years, who receive regular surveillance for hepatocellular carcinoma. * patients with risk index greater than 2.33, corresponding to the annual 5% risk of hepatocellular carcinoma development. * risk index = 1.65 (if the prothrombin activity was ≤ 75%) + 1.41 (if the age was 55 years or older) + 0.92 (if the platelet count was \< 75 x103/mm3) + 0.74 (if the presence of anti-hepatitis c virus was positive). exclusion criteria: * history of malignancy diagnosis including hepatocellular carcinoma * impaired renal function (estimated glomerular filtration rate \<30 ml/min/1.73m2) * impaired hepatic function (child-pugh class c) * patients who are not eligible for voluntary consent
therapeutic education consultations with diabetic patients treated with intensified insulin therapy

Conditions: Diabete Mellitus; Insulin Dependent Diabetes

Summary: diabetes is a chronic condition that affects around 8% of the french population, and is associated with severe complications. maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.insulin can be administered by injection via syringes or pens, or by insulin pumps and patients can perform self-monitoring of blood glucose. all these actions can be the subject of therapeutic education, which involves a range of tools, including dedicated individual consultations carried out by state-qualified nurses. the aim of the study is to evaluate the benefit of therapeutic education consultations conducted by nurses in addition to medical consultations, on the follow-up of diabetic patients, insulin pump carriers or treated with multiple injections, in terms of glycemic control, quality of life and medical complications. the objective of the study is to evaluate whether the therapeutic education consultations conducted by nurses can improve the care of the diabetic patient.


Eligibility criteria:
inclusion criteria: * woman or man aged 18 to 75 * diabetic patient type 1 or 2 insulin-dependent * patient treated with multi-injections or insulin pump * patient equipped with freestyle libre flash glucose monitoring system * glycemic imbalance with hba1c \> 8 * patient living at home exclusion criteria: * recent discovery (\< 6 months) of diabetes * major intellectual disability * social isolation * imc \> 35 * pregnant women
stay well at home: a text-messaging study social distancing

Conditions: Depressive Symptoms; Anxiety; COVID-19

Summary: the investigators have developed supportive text-messages in english and spanish to help people cope with the stress and anxiety of covid-19 social distancing. the purpose of this study is to examine if automated text-messages will improve depression and anxiety symptoms and enhance positive mood. additionally, the investigators will compare the effectiveness of sending messages on a random schedule (using a micro-randomized trial design) or sent by a reinforcement learning policy on overall change in depression and anxiety symptoms and daily mood during the 8-week study.

the investigators will send participants supportive text-messages for a period of 2 months. these text-messages will include tips about behavioral activation and coping skills to deal with worries and stress. the investigators generated a message bank balanced such that 50% of all messages are related to behavioral activation (ba) and 50% messages involve different coping skills. participants will receive one of these messages per day between 9:00 am and 6:00 pm. participants will also receive a message asking them to rate their mood on a scale of 1-9 once a day 3 hours after the ba or coping message. participants will be randomized to: 1. a uniform random messaging group (micro-randomized trial design). 2. a reinforcement learning group with a learned decision mechanism for the timing and type of text-message. the algorithm learns from previous data (which messages were sent, what was the participants' mood) to maximize an increase in participants mood. no other data are collected from participants' phones. the investigators will compare the effect of sending text-messages by a random schedule, and text-messaging chosen by the rl algorithm. this allows to both evaluate the effect of the individual intervention components over time within a micro-randomized trial design, and assess the added value of using rl to adapt the messaging scheme. the investigators hypothesize that: * participant will show improvements in depression, anxiety symptoms and mood during the 60 day study. * the participants in the group receiving reinforcement learning will have a greater improvement in depressive symptoms, anxiety and positive mood during the study than participants in the micro-randomized group. * the investigators will find differential effects on mood ratings for the two categories of messages

Eligibility criteria:
inclusion criteria: * over 18 years old * own a mobile phone * speak english or spanish exclusion criteria: * not owning a mobile phone * under 18 years old

Keywords: mobile health text-messaging covid-19 mental health coping